The main objectives of the SRD part of this trial are to investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1356225 in healthy male subjects following oral administration of single rising doses. The main objective of the BA part of this trial will be to explore the influence of food on the bioavailability of tablet fasted versus tablet fed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
Oral Dose
Oral dose
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
The primary endpoint for assessment of safety and tolerability of BI 1356225 is the percentage of subjects with drug-related adverse events (both trial parts)
Time frame: Up to 30 days
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 30 days
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 30 days
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